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Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01109069
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : May 7, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Study Description
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Brief Summary:
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diffuse Well-differentiated Lymphocytic Lymphoma B Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Non-Hodgkin's Lymphoma Waldenstrom Macroglobulinemia Burkitt Lymphoma B-Cell Diffuse Lymphoma Drug: PCI-32765 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
Study Start Date : June 2010
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: PCI-32765 Drug: PCI-32765
Dose based on parent protocol


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Adverse Events [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]
    Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.


Secondary Outcome Measures :
  1. Progressive Disease (PD) [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]
    A progressive disease confirmed by a CT scan.

  2. Death Event [ Time Frame: 30 days after last dose of study drug ]
    All death events are due to AE, progressive disease, and other reasons.

  3. Documented Responses [ Time Frame: 30 days after last dose of study drug, continue up to 6 months ]
    Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
  • Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
  • Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion Criteria:

  • A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
  • Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
  • Lactating or pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109069


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Stanford, California, United States, 94305
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, New York
New Hyde Park, New York, United States, 11042
New York, New York, United States, 10065
Rochester, New York, United States, 14642-0001
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Oregon
Springfield, Oregon, United States, 97477
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Houston, Texas, United States, 77030
Tyler, Texas, United States, 75702
United States, Vermont
Fletcher Allen Health Care and University of Vermont
Burlington, Vermont, United States, 05405
United States, Washington
Vancouver, Washington, United States, 98684
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
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Study Director: James Dean, MD Medical Monitor
  Study Documents (Full-Text)

Documents provided by Pharmacyclics LLC.:
Study Protocol  [PDF] May 14, 2015
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01109069    
Other Study ID Numbers: PCYC-1103-CA
PCI-32765 ( Other Identifier: Pharmacyclics )
First Posted: April 22, 2010    Key Record Dates
Results First Posted: May 7, 2020
Last Update Posted: May 27, 2020
Last Verified: March 2020
Keywords provided by Pharmacyclics LLC.:
PCI-32765
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Bruton's Tyrosine Kinase
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Lymphoma, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Leukemia, B-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders